EBR Systems (ASX:EBR) said the US Centers for Medicare and Medicaid Services (CMS) initiated a National Coverage Determination to evaluate Medicare coverage for leadless left ventricular endocardial pacing (LVEP) used in cardiac resynchronization therapy, as a result of EBR's engagement with CMS through the Transitional Coverage for Emerging Technologies (TCET) pathway, according to a Thursday Australian bourse filing.

EBR is working toward CMS's projected timeline, which would deliver potential coverage determination approval for the Wireless Stimulation Endocardially (WiSE) system by early 2027.

Under the coverage determination process, CMS will conduct a national coverage analysis to study whether a medical technology meets the statutory standard of being reasonable and necessary for Medicare beneficiaries. A positive coverage determination outcome will support broader Medicare coverage, expanded patient access, and accelerated US commercialization efforts.